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To evaluate the effect of multiple doses of BIIL 284 BS on the pharmacokinetics of a single dose of theophylline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIL 284 BS with theophylline | Experimental |
| |
| Placebo with theophylline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIL 284 BS | Drug |
| ||
| Theophylline |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma levels of theophylline | up to 72 hours after theophylline administration | |
| Area under the curve from zero extrapolated to infinity (AUC0-infinity) | up to 72 hours after theophylline administration | |
| Peak plasma concentration (Cmax) for theophylline | up to 72 hours after theophylline administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to peak plasma concentration (tmax) | up to 72 hours after theophylline administration | |
| Terminal half-life (t1/2) | up to 72 hours after theophylline administration | |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C424425 | amelubant |
| D013806 | Theophylline |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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|
| Placebo | Drug |
|
| Total mean residence time (MRTtot) |
| up to 72 hours after theophylline administration |
| Total clearance after oral administration (CLtot/F) | up to 72 hours after theophylline administration |
| Volume of distribution during terminal phase after oral administration (Vz/F) | up to 72 hours after theophylline administration |
| Area under the concentration time curve at steady state (AUC,ss) for BIIL 315 ZW | up to 72 hours after theophylline administration |
| Peak plasma concentration at steady state (Cmax,ss) for BIIL 315 ZW | up to 72 hours after theophylline administration |
| Number of patients with adverse events | up to 5 days after last theophylline administration |
| Number of patients with clinically significant findings in vital signs | up to 3 days after last drug administration |
| Number of patients with clinically significant findings in laboratory tests | up to 3 days after last drug administration |
| Number of patients with clinically significant findings in 12-lead ECG | up to 3 days after last drug administration |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |